Biocardia Phase 3 CardiAMP-HF Trial of Novel Cardiac Cell Therapy for Ischemic Heart Failure Shows Increased Survival, Decreased Cardiac Events, and Improved Quality of Life at Two Years
BioCardia (NASDAQ: BCDA) announced two-year outcomes from its Phase 3 CardiAMP-HF study, evaluating CardiAMP autologous cell therapy for ischemic heart failure patients with reduced ejection fraction. The trial, involving 115 patients across 18 centers in the US and Canada, showed promising results.
In patients with elevated NTproBNP biomarkers (50% of enrolled patients), the therapy demonstrated:
- 13% fewer heart death equivalents with 47% relative risk reduction
- 2% fewer non-fatal major adverse cardiac events with 16% risk reduction
- 10.5-point improvement in quality-of-life scores
Overall results showed 3.6% fewer heart death equivalents, 8.7% fewer non-fatal adverse events, and meaningful quality of life improvements. The FDA-designated Breakthrough Therapy incorporates three proprietary elements: pre-procedural cell analysis, high target cell dosage, and a minimally-invasive delivery system.
BioCardia (NASDAQ: BCDA) ha annunciato i risultati a due anni del suo studio di Fase 3 CardiAMP-HF, che valuta la terapia cellulare autologa CardiAMP per pazienti con insufficienza cardiaca ischemica e frazione di eiezione ridotta. Lo studio, che ha coinvolto 115 pazienti in 18 centri negli Stati Uniti e in Canada, ha mostrato risultati promettenti.
Nei pazienti con biomarcatori NTproBNP elevati (il 50% dei pazienti arruolati), la terapia ha dimostrato:
- 13% in meno di equivalenti di morte cardiaca con una riduzione del rischio relativo del 47%
- 2% in meno di eventi avversi cardiaci maggiori non fatali con una riduzione del rischio del 16%
- un miglioramento di 10,5 punti nei punteggi di qualità della vita
I risultati complessivi hanno mostrato un 3,6% in meno di equivalenti di morte cardiaca, un 8,7% in meno di eventi avversi non fatali e significativi miglioramenti della qualità della vita. La terapia designata come Breakthrough Therapy dalla FDA incorpora tre elementi proprietari: analisi cellulare pre-procedurale, alta dose di cellule target e un sistema di somministrazione minimamente invasivo.
BioCardia (NASDAQ: BCDA) anunció los resultados a dos años de su estudio de Fase 3 CardiAMP-HF, que evalúa la terapia celular autóloga CardiAMP para pacientes con insuficiencia cardíaca isquémica y fracción de eyección reducida. El ensayo, que involucró a 115 pacientes en 18 centros en EE. UU. y Canadá, mostró resultados prometedores.
En pacientes con biomarcadores de NTproBNP elevados (el 50% de los pacientes inscritos), la terapia demostró:
- 13% menos equivalentes de muerte cardíaca con una reducción del riesgo relativo del 47%
- 2% menos eventos adversos cardíacos mayores no fatales con una reducción del riesgo del 16%
- mejora de 10.5 puntos en las puntuaciones de calidad de vida
Los resultados generales mostraron un 3.6% menos de equivalentes de muerte cardíaca, un 8.7% menos de eventos adversos no fatales y mejoras significativas en la calidad de vida. La terapia designada como Breakthrough Therapy por la FDA incorpora tres elementos propietarios: análisis celular pre-procedimental, alta dosis de células objetivo y un sistema de entrega mínimamente invasivo.
BioCardia (NASDAQ: BCDA)는 심박출률이 감소한 허혈성 심부전 환자를 위한 CardiAMP 자가세포 요법을 평가하는 3상 CardiAMP-HF 연구의 2년 결과를 발표했습니다. 이 시험은 미국과 캐나다의 18개 센터에서 115명의 환자를 대상으로 진행되었으며, 유망한 결과를 보여주었습니다.
NTproBNP 바이오마커가 높은 환자들(등록된 환자의 50%)에서 이 요법은 다음과 같은 결과를 나타냈습니다:
- 심장 사망 동등체가 13% 감소하고 상대 위험이 47% 감소
- 비치명적인 주요 심장 사건이 2% 감소하고 위험이 16% 감소
- 삶의 질 점수가 10.5점 향상
전체 결과는 심장 사망 동등체가 3.6% 감소하고 비치명적인 사건이 8.7% 감소했으며, 삶의 질이 의미 있게 향상되었음을 보여주었습니다. FDA가 지정한 돌파구 요법은 세 가지 독점 요소를 포함합니다: 시술 전 세포 분석, 높은 목표 세포 용량, 그리고 최소 침습적 전달 시스템입니다.
BioCardia (NASDAQ: BCDA) a annoncé les résultats à deux ans de son étude de Phase 3 CardiAMP-HF, évaluant la thérapie cellulaire autologue CardiAMP pour les patients souffrant d'insuffisance cardiaque ischémique avec une fraction d'éjection réduite. L'essai, impliquant 115 patients dans 18 centres aux États-Unis et au Canada, a montré des résultats prometteurs.
Chez les patients avec des biomarqueurs NTproBNP élevés (50% des patients inscrits), la thérapie a démontré :
- 13% d'équivalents de décès cardiaque en moins avec une réduction du risque relatif de 47%
- 2% d'événements cardiaques majeurs non fatals en moins avec une réduction du risque de 16%
- une amélioration de 10,5 points des scores de qualité de vie
Les résultats globaux ont montré 3,6% d'équivalents de décès cardiaque en moins, 8,7% d'événements adverses non fatals en moins et des améliorations significatives de la qualité de vie. La thérapie désignée comme thérapie innovante par la FDA intègre trois éléments propriétaires : analyse cellulaire pré-procédurale, dosage élevé de cellules cibles et un système d'administration minimalement invasif.
BioCardia (NASDAQ: BCDA) hat die zweijährigen Ergebnisse seiner Phase-3-Studie CardiAMP-HF bekannt gegeben, die die autologe Zelltherapie CardiAMP bei Patienten mit ischämischer Herzinsuffizienz und reduzierter Ejektionsfraktion bewertet. Die Studie, in der 115 Patienten an 18 Zentren in den USA und Kanada beteiligt waren, zeigte vielversprechende Ergebnisse.
Bei Patienten mit erhöhten NTproBNP-Biomarkern (50% der eingeschriebenen Patienten) zeigte die Therapie:
- 13% weniger Herzsterblichkeit mit einer relativen Risikominderung von 47%
- 2% weniger nicht-tödliche schwere kardiale Ereignisse mit einer Risikominderung von 16%
- 10,5 Punkte Verbesserung der Lebensqualität
Die Gesamtergebnisse zeigten 3,6% weniger Herzsterblichkeit, 8,7% weniger nicht-tödliche adverse Ereignisse und signifikante Verbesserungen der Lebensqualität. Die von der FDA als Durchbruchtherapie bezeichnete Therapie umfasst drei proprietäre Elemente: prä-prozedurale Zellanalysen, hohe Zielzell-Dosierung und ein minimal-invasives Abgabesystem.
- 47% relative risk reduction in heart death equivalents for high-risk patients
- Significant quality of life improvements with 10.5-point score increase in key patient group
- Durable benefits observed through two years post-treatment
- FDA Breakthrough Therapy designation received
- Large addressable market of 1 million US patients worth $30B annually
- Primary composite efficacy endpoint did not reach statistical significance
- Benefits primarily to subset of patients with elevated NTproBNP (50% of enrolled patients)
- Modest improvements in left ventricular ejection fraction observed in both treated and control groups
Insights
The CardiAMP-HF trial results present a mixed clinical outcome for BioCardia's cell therapy. While the study failed to meet its primary composite efficacy endpoint - typically a significant regulatory hurdle - several meaningful secondary outcomes provide important context. The durability of benefits through two years from a single treatment is particularly noteworthy.
Most promising is the statistically significant improvement in the biomarker-positive subgroup (elevated NTproBNP/BNP), representing approximately 50% of patients. This population showed substantial benefits:
The identification of this responsive subgroup creates a potential regulatory pathway focused on biomarker-selected patients - a population the company estimates at one million patients in the US alone. The FDA's Breakthrough Therapy designation may provide regulatory flexibility despite the missed primary endpoint.
However, investors should note the modest size of this Phase 3 trial (115 patients across 18 centers), which raises questions about statistical power. The complex results create regulatory uncertainty, though the safety profile appears favorable with no reported concerns, and the therapy addresses a substantial unmet need in patients unresponsive to standard medications.
BioCardia's CardiAMP cell therapy targets a critical gap in heart failure management - patients with reduced ejection fraction who remain symptomatic despite optimal medical therapy. The mechanism, which appears to improve capillary density, blood flow, and reduce fibrosis, represents a novel approach to addressing cardiac remodeling.
The clinical improvements observed deserve attention: reduced mortality, fewer major cardiac events, and improved quality of life metrics. Particularly impressive is the
The biomarker-stratified results align with the evolving paradigm of precision medicine in cardiology. The substantial benefit in patients with elevated NTproBNP suggests this therapy could be targeted to those experiencing active cardiac stress, potentially offering an intervention before disease progression accelerates. The 13.9-meter improvement in six-minute walk distance in this subgroup represents clinically meaningful functional enhancement.
While the primary endpoint wasn't achieved, the constellation of benefits across survival, cardiac events, and quality metrics suggests genuine biological activity that could meaningfully impact patient outcomes in this difficult-to-treat population.
- Increased survival and reduced major adverse cardiac and cerebrovascular events (MACCE) observed study-wide, despite primary composite efficacy endpoint not reaching statistical significance
- Statistically significant improvement in composite outcome measure comprised of survival, MACCE, and quality of life seen in patients suffering from active heart stress (those with elevated NTproBNP and BNP biomarkers) treated with CardiAMP Cell Therapy
- Patient improvements through two years suggest single dose of CardiAMP therapy offers durable benefits
SUNNYVALE, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced two-year outcomes from the double-blind randomized placebo-controlled Phase 3 CardiAMP-HF study of its CardiAMP autologous minimally invasive cell therapy for the treatment of ischemic heart failure in patients with reduced ejection fraction (HFrEF). Results were presented yesterday as a late-breaking clinical trial at the American College of Cardiology’s Annual Scientific Session and Expo by co-principal investigator Amish N. Raval, MD, FACC, professor of medicine at the University of Wisconsin School of Medicine and Public Health.
“This clinical trial was conducted because there remains a large group of heart failure patients today who are insufficiently responsive to optimized heart failure medication. In this rigorous CardiAMP-HF Trial, patients who received the novel cell therapy adjunctive to medication experienced decreased mortality and MACCE, with improved quality of life, when compared to those on medication alone. These benefits appeared to be greater in patients with elevated NTproBNP - comprising fully half of treated patients - reaching statistical significance in the composite measure of these outcomes,” Dr. Raval said. “The trial shows us that CardiAMP therapy has the potential to safely and significantly improve survival and quality of life for heart failure patients in distress, encompassing a large group of patients we see in daily practice.”
The CardiAMP-HF Trial studied 115 ischemic heart failure patients with reduced ejection fraction (HFrEF) enrolled at 18 centers in the United States and Canada. All patients studied were maintained on heart failure medication, with treated patients receiving a single dose of CardiAMP Cell Therapy adjunctive to medication. Two-year results from the trial demonstrated:
- In patients with elevated NTproBNP biomarkers (
50% of enrolled patients) compared to patients on optimized heart failure medication regimens alone:13% fewer heart death equivalents (all-cause death, heart transplantation, left ventricular assist device implantation);47% relative risk reduction in heart death equivalents2% fewer non-fatal major adverse cardiac and cerebrovascular events MACCE;16% relative risk reduction in MACCE- Clinically meaningful 10.5-point improvement in quality-of-life score, as measured by Minnesota Living with Heart Failure Questionnaire (MLHFQ)
- 13.9-meter improvement in Six Minute Walk Distance
- In all treated patients compared to patients on optimized heart failure medication regimen alone:
3.6% fewer heart death equivalents;20.9% relative risk reduction in heart death equivalents8.7% fewer non-fatal MACCE;44.6% relative risk reduction in non-fatal MACCE- Clinically meaningful 5.5-point improvement in quality of life score, as measured by MLHFQ
14% fewer non-sustained ventricular tachyarrythmias and5.5% fewer sustained ventricular tachyarrhythmias- Although both treated and controlled patients saw modest improvements in left ventricular ejection fraction, treated patients also showed evidence of reduced left ventricular end diastolic and end systolic volumes
“It is interesting to note that the results for this therapy were durable at two years, suggesting the therapy may have lasting benefits for the heart that may help prevent disease progression,” said Carl Pepine, MD, co-principal investigator of the CardiAMP-HF Trial and professor of medicine with the University of Florida. “It is an exciting prospect to anticipate an addition to our heart failure armamentarium that can meaningfully improve patients’ lives to an extent that many don’t enjoy today.”
Designated by the FDA as a Breakthrough Therapy with significant potential to improve upon current therapies, CardiAMP Cell Therapy incorporates three proprietary elements not previously utilized in cardiac cell therapy: 1) a pre-procedural cell analysis to identify likely responders, 2) a high target dosage of cells, and 3) a minimally-invasive system for cell therapy delivery to the damaged area of the heart that has been shown to be safer and promote greater cell retention than other intramyocardial delivery systems.
“The patient benefits suggested by this trial help to clinically validate our therapy’s observed mechanism of action for improving capillary density and promoting greater blood flow, and decreasing fibrosis leading to healthier cardiac tissue,” said Peter Altman, PhD, BioCardia President and CEO. “The group of high responders to CardiAMP therapy represents a market of approximately one million patients in the United States alone, who today cost the healthcare system
About CardiAMP Autologous Cell Therapy
Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response to increase capillary density, reduce tissue fibrosis, and ultimately treat microvascular dysfunction. The mechanisms that lead to microvascular dysfunction, including fibrotic, inflammatory, apoptotic, and endothelial autonomic dysfunction, are all targets of CardiAMP cell therapy, largely through production of growth factors, cytokines, chemokines, and other factors that directly counteract each of these mechanisms.
The CardiAMP clinical development for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS).
CAUTION - Limited by United States law to investigational use.
The two-year CardiAMP-HF results will be addressed in a conference call scheduled for Monday, March 31, 2025 at 4:30pm PDT. To access the call:
Participants can register for the conference by navigating to https://dpregister.com/sreg/10194429/fdf5f0e427. Please note that registered participants will receive their dial-in number upon registration. For those who have not registered, to listen to the call by phone, interested parties within the U.S. should call 1-833-316-0559 and international callers should call 1-412-317-5730 and ask to be connected to the BioCardia call. All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the BioCardia call. The conference call will also be available through a live webcast, which can be accessed through the following link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=fmwk6hNm.
A webcast replay of the call will be available approximately one hour after the end of the call at the above links. To access the replay internationally, please use the link https://services.choruscall.com/ccforms/replay.html. A telephonic replay of the call will be available and may be accessed by calling 1-877-344-7529 (domestic), 1-412-317-0088 (international) or 855-669-9658 (Canada) by using access code 6220156.
About BioCardia®
BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms. For more information, visit www.biocardia.com.
Forward Looking Statements
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the Company’s investigational product candidates, the timing of availability of data from this trial, the likelihood, magnitude and durability of safety and patient benefit, potential reductions in future health care costs, market opportunities, statements related to the mechanisms of action of the CardiAMP Cell Therapy and potential future regulatory approvals. These forward-looking statements are made as of the date of this press release.
We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 26, 2025, under the caption titled “Risk Factors.” BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
References:
(1) Heidenreich PA, Fonarow GC, Opsha Y, Sandhu AT, Sweitzer NK, Warraich HJ; HFSA Scientific Statement Committee Members Chair. Economic Issues in Heart Failure in the United States. J Card Fail. 2022 Mar;28(3):453-466. doi: 10.1016/j.cardfail.2021.12.017. Epub 2022 Jan 24. PMID: 35085762; PMCID: PMC9031347.
Media Contact: Michelle McAdam, Chronic Communications Inc. michelle@chronic-comm.com, 310-902-1274 Investor Relations Contact: David McClung, Chief Financial Officer investors@biocardia.com, 650-226-0120
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